Efficacy of a yeast postbiotic on cold/flu symptoms in healthy children: A randomized-controlled trial.

BACKGROUND: Children attending school/daycare are at high risk of acute respiratory tract infections. EpiCorTM postbiotic, derived from yeast fermentate, has been demonstrated to improve immune function in adults, reducing the incidence of cold/flu-like or allergy symptoms. As such, studies are warranted in children as available pharmaceutical options have unwanted side effects. METHODS: Two-hundred and fifty-six children aged 4-12 years attending school/daycare were randomized to either EpiCor or Placebo for 84 days during the 2022-2023 flu season in Ontario, Canada. The Canadian Acute Respiratory Illness and Flu Scale (CARIFS) and study diary assessed the incidence and severity of cold/flu symptoms and the use of cold/flu medications. Adverse events were recorded. RESULTS: Total CARIFS severity scores, 'sore throat' and 'muscle aches or pains' symptom scores in the EpiCor group were significantly lower compared to Placebo during incidences of cold/flu (P ≤ 0.05). Participants taking Placebo were 1.73 times more likely to use cold/flu medication compared to those receiving EpiCor (P = 0.04). The incidence of cold/flu symptoms was not significantly different between groups. EpiCor was found to be safe and well-tolerated. CONCLUSIONS: EpiCor supplementation resulted in significantly lower cold/flu symptom severity and less cold/flu medication usage than Placebo demonstrating a beneficial effect on immune function in children. IMPACT: Children are at high risk of acquiring cold/flu infections and safe and efficacious mitigating regimens are lacking. Children supplemented daily with 500 mg EpiCorTM postbiotic derived from yeast fermentate had significantly lower overall cold/flu symptom severity, and severity of sore throat and muscle aches or pains over the 84-day supplementation period. EpiCor supplementation resulted in decreased use of traditional cold/flu medication. Daily supplementation with 500 mg of EpiCor for 84 days was safe and well tolerated by healthy children aged 4-12 years attending school or daycare.

Safety and Efficacy of AlphaWave® L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Prolonged periods of stress may lead to negative health consequences. AlphaWave® L-Theanine was safe and efficacious during an acute stress challenge. However, double-blind, placebo-controlled clinical trials investigating the longer term effects of L-theanine supplementation on stress are warranted. METHODS: Thirty healthy adults (18-65 years) with moderate stress were randomized to AlphaWave® L-Theanine (400 mg L-theanine/day) or placebo (n = 15/group) for 28 days. Stress was assessed by salivary cortisol, Perceived Stress Scale (PSS) and Depression, Anxiety and Stress Scale-21; sleep was assessed by the Healthy People Sleep Quality Index and actigraphy device; cognition was assessed by Computerized Mental Performance Assessment System; mood was assessed by Profile of Mood States. All outcomes were measured at baseline, Days 14 and 28. Safety included vital signs, clinical chemistry, haematology and adverse events (AEs). RESULTS: All AEs were resolved by the end of the study period or upon subsequent follow up, and out of range laboratory values and changes in vital signs were deemed not clinically relevant following AlphaWave® L-Theanine supplementation. Participants supplemented with AlphaWave® L-Theanine had decreases of 12.92% (p = 0.051) and 17.98% (p = 0.04) in PSS scores after 14 and 28 days, respectively, while those on placebo had respective decreases of 9.74% (p = 0.061) and 17.88% (p = 0.009). There were no significant differences between groups for change in salivary cortisol. The AlphaWave® L-Theanine group demonstrated decreased time asleep after 28 days and significantly reduced light sleep after 14 and 28 days compared to placebo (p ≤ 0.040). The AlphaWave® L-Theanine group significantly improved by 21.79% and 21.33% in Stroop test correct reaction time after 14 and 28 days, respectively, while those on placebo improved after 28 days only (p = 0.005). CONCLUSIONS: AlphaWave® L-Theanine supplementation for 28 days was safe and significantly decreased perceived stress significantly decreased perceived stress and light sleep, improved sleep quality and enhanced cognitive attention in the studied population. Larger, randomized controlled trials with longer duration of AlphaWave® L-Theanine supplementation are warranted to reduce inter-individual variability and the potential placebo effect. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05808595.

Examining the Systemic Bioavailability of Cannabidiol and Tetrahydrocannabinol from a Novel Transdermal Delivery System in Healthy Adults: A Single-Arm, Open-Label, Exploratory Study.

INTRODUCTION: Transdermal cannabinoids may provide better safety and bioavailability profiles compared with other routes of administration. This single-arm, open-label study investigated a novel topical transdermal delivery system on the pharmacokinetics of cannabidiol (CBD) and tetrahydrocannabinol (THC). METHODS: Participants were 39.5 ± 7.37 years old and healthy, based on a review by the Medical Director. Blood was collected pre-dose and 10, 20, 30, and 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 h after topical application of 100 mg CBD:100 mg THC. Psychoactive effects were assessed prior to each timepoint. Area-under-the-curve (AUC0-12 h), maximum concentration (Cmax), time to maximum concentration (Tmax), area-under-the-curve to infinity (AUCI), terminal elimination rate constant (λ), terminal half-life (t½), and absorption rate constant (ka) were measured individually for CBD and THC. Safety was assessed by clinical chemistry, hematology, and adverse events. RESULTS: AUC0-12 h for CBD and THC was 3329.8 ± 3252.1 and 2093.4 ± 2090.6 pg/mL/h, with Cmax of 576.52 ± 1016.18 and 346.57 ± 776.85 pg/mL, respectively. Tmax for CBD and THC was 8 h, ranging from 2.5 h to 12 h and 10 min to 12 h, respectively. AUCI for CBD and THC was 6609.2 ± 7056.4 and 3721.0 ± 3251.7 pg/mL/h, with t1/2 of 5.68 ± 1.5 and 5.38 ± 1.25 h, respectively. CBD was absorbed at a faster rate compared with THC (123.36 ± 530.97 versus 71.5 ± 1142.19 h-1) but with similar λ (0.12 ± 0.029 versus 0.13 ± 0.03 h-1). No psychoactive effects were reported. Transdermal cannabinoid delivery was safe and well tolerated in the population studied. CONCLUSION: To our knowledge, this is the first pharmacokinetic study in humans that demonstrated CBD and THC entering systemic circulation via transdermal administration . This study represents an important contribution to understanding the pharmacokinetics of transdermal cannabinoids. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier-NCT05121506 (November 16, 2021).

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ formula in healthy participants with occasional sleeplessness.

The purpose of this study was to investigate the safety and efficacy of Rest-ZZZ, a natural sleep supplement, in healthy adults without a diagnosed sleep disorder. This randomized, double-blind, placebo-controlled, cross-over study consisted of three 7-day supplementation periods with either Rest-ZZZ, Diphenhydramine (DPH), or Placebo, with a 7-day washout. Twenty-seven participants were randomized to one of three intervention sequences and the Healthy People Sleep Quality Index (HPSQI), Quality of Life (QoL), and Profile of Mood States (POMS) questionnaires were assessed at the beginning and end of each supplementation period. Rest-ZZZ and Placebo showed improvements in sleep-related QoL (p ≤ 0.044) and total mood disturbance (TMD) (p = ≤ 0.028). Fatigue-Inertia was reduced by all study products (p ≤ 0.031). DPH did not result in any significant improvements on sleep quality parameters. A subgroup analysis of participants ≤ 45 years found enhanced efficacy of Rest-ZZZ and improvement in sleep-related QoL vs. Placebo (p = 0.007), as well as improvements in sleep duration (p = 0.007), sleep debt (p = 0.011), and sleep-related QoL (p = 0.033). DPH supplementation resulted in significant improvement in only sleep debt (p = 0.038). Rest-ZZZ had a safe hematology and chemistry profile. Rest-ZZZ resulted in restful sleep that generated corresponding improvements in sleep-related QoL and overall mood. Rest-ZZZ is an efficacious sleep supplement with a favorable safety profile, particularly in those aged 25-45 years.

Association between efficiency and quality of care of public healthcare facilities: Evidence from Pakistan.

BACKGROUND: Maternal and child health is an important component of the Sustainable Development Goals. Pakistan has one of the worst maternal and neonatal health outcomes in the world. This is despite significant health system investments across the country. AIMS: The objectives of this study are twofold. First, the study estimates the technical efficiency of the public healthcare facilities in Pakistan, defined as the number of obstetric deliveries compared to the number of medical specialists, nurses, and other health and non-health staff members. Second, the study evaluates the relationship between efficiency and quality of care; the latter is measured in terms of maternal and neonatal mortality. MATERIALS & METHODS: The data were taken from the Pakistan Health Facility Assessment Survey. Efficiency score was calculated for 843 public healthcare facilities, using Stochastic Frontier Analysis. We then used two-stage residual inclusion approach with bootstrapping to evaluate the relationship between efficiency and quality. RESULTS AND DISCUSSION: The average efficiency score was 0.48 (range: 0-1) and none of the public healthcare facilities were on the frontier, implying that efficiency gains can be made across the board. The relationship between efficiency and quality is found to be positive and statistically significant, that is, more efficient healthcare facilities also had lower rates of maternal and neonatal mortality. CONCLUSION: We conclude that more efficient public healthcare facilities also had lower mortality rates, probably due to better infrastructure and health system financing.

Using mixed-method feasibility studies to examine the impact of a mobile standing desk on undergraduates' sedentary time.

OBJECTIVES: To understand experiences with and measure the effect of mobile standing desks (MSD) on undergraduates' sedentary time (ST). PARTICIPANTS: Two samples of full-time undergraduates in Fall 2018. METHODS: Study 1 (n = 21): baseline average daily ST was measured via activPAL4TM inclinometers and the NIGHTLY-WEEK-U questionnaire for 7 days. Participants received a MSD for one week then intervention ST was calculated. Study 2 (n = 28): baseline ST was measured with an online NIGHTLY-WEEK-U questionnaire, participants received a MSD for one month, then intervention ST was calculated. Paired-sample t-tests assessed differences. Interviews/online questions explored experiences. RESULTS: Study 1: objectively measured (p = .0045, d = .71) and self-report (p = .0005, d = .92) ST reduced significantly post-intervention. Study 2: ST reduced significantly post-intervention (p = < .0001, d = .98). Facilitators and barriers to desk usage were described. CONCLUSIONS: MSD were effective for reducing undergraduates' ST across one-week and one-month.

Are COVID-19 models blind to the social determinants of health? A systematic review protocol.

INTRODUCTION: Infectious disease models are important tools to inform public health policy decisions. These models are primarily based on an average population approach and often ignore the role of social determinants in predicting the course of a pandemic and the impact of policy interventions. Ignoring social determinants in models may cause or exacerbate inequalities. This limitation has not been previously explored in the context of the current pandemic, where COVID-19 has been found to disproportionately affect marginalised racial, ethnic and socioeconomic groups. Therefore, our primary goal is to identify the extent to which COVID-19 models incorporate the social determinants of health in predicting outcomes of the pandemic. METHODS AND ANALYSIS: We will search MEDLINE, EMBASE, Cochrane Library and Web of Science databases from December 2019 to August 2020. We will assess all infectious disease modelling studies for inclusion of social factors that meet the following criteria: (a) focused on human spread of SARS-CoV-2; (b) modelling studies; (c) interventional or non-interventional studies; and (d) focused on one of the following outcomes: COVID-19-related outcomes (eg, cases, deaths), non-COVID-19-related outcomes (ie, impacts of the pandemic or control policies on other health conditions or health services), or impact of the pandemic or control policies on economic outcomes. Data will only be extracted from models incorporating social factors. We will report the percentage of models that considered social factors, indicate which social factors were considered, and describe how social factors were incorporated into the conceptualisation and implementation of the infectious disease models. The extracted data will also be used to create a narrative synthesis of the results. ETHICS AND DISSEMINATION: Ethics approval is not required as only secondary data will be collected. The results of this systematic review will be disseminated through peer-reviewed publication and conference proceedings. PROSPERO REGISTRATION NUMBER: CRD42020207706.

Sedentary time among undergraduate students: A systematic review.

OBJECTIVE: To systematically review and synthesize all relevant literature to assess the range of average daily sedentary time (ST) of undergraduate students enrolled in university and college programs across the world. Methods: Published, peer-reviewed articles were included if they: (a) were in English; (b) had a study population that consisted entirely of undergraduate students; (c) reported a daily or weekly ST for undergraduate students; and (d) included a measure of ST using a valid sedentary behavior questionnaire or accelerometers. Results: Twenty-three studies were included in the review. A wide range of ST (0.75 to 14.35 hours per day) was reported. Mean ST as measured by domain-specific questionnaires and accelerometers was 11.10 hours per day and 10.69 hours per day, respectively. Conclusion: Findings suggest that some undergraduate students participate in high levels of ST. Additional research, as well as interventions focused on reducing ST among postsecondary students, are needed.

Feasibility of DriveFocus™ and Driving Simulation Interventions in Young Drivers.

Motor vehicle collisions are the leading cause of death among North American youth, with a high prevalence of distraction-related fatalities. Youth-focused interventions must address detecting (visual scanning) and responding (adjustment to stimuli) to critical roadway information. In this repeated measures study, we investigated the feasibility (i.e., recruitment and sample characteristics; data collection procedures; acceptability of the intervention; resources; and preliminary effects) of a DriveFocus™ app intervention on youth's driving performance. Thirty-four youth participated in a 9-week protocol (retention rate = 89.7%; adherence rate = 100%). No participants experienced simulator sickness. A preliminary nonparametric evaluation of the results ( n = 34) indicated a statistically significant decrease in the number of visual scanning, F(2, 68) = 3.769, p = .028, and adjustment to stimuli, F(2, 68) = 6.759, p = .002, errors between baseline, midpoint, and posttest. This study lays the foundation to support a targeted intervention trial to improve youth's attention to critical road information, building on their mobile technology preferences.